This report reviews the deeply concerning Form 483 to Jiangsu Hengrui Pharmaceuticals, a China-based manufacturer, on January 16, 2024, during an inspection classified as Official Action Indicated (OAI).

The inspection revealed eight primary observations, six of which were graded as Critical by Redica Systems’ Quality System Risk Models. Nine out of 29 were deemed Critical when including secondary observations, painting a troubling picture of the company’s quality control practices.

Download this report to see the detailed observations and to learn more about Redica Systems’ Site Risk Scoring.